Apparatus for treating a mitral valve

• US 8,926,691 B2
• Filed: 09/12/2013
• Issued: 01/06/2015
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe E., Yi, Seung-Beom, Geist, Stephen C., Oba, Travis
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/025,594
• Publication Number:
  US 20140012372A1
• Time in Patent Office: 481 Days
• Field of Search: 623 124- 126, 623 21- 219, 606/108
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Embodiments of an apparatus for treating a deficient mitral valve include an expandable spacer configured for placement between the native leaflets of the mitral valve, the spacer anchorable to a wall of the ventricle. Methods and apparatus for delivering and implanting the prosthetic are also described.

Claims

1. A method of implanting a prosthetic spacer at the native mitral valve region of the heart, the native mitral valve having anterior and posterior native valve leaflets, the method comprising:

positioning a blood-impermeable spacer body of the prosthetic spacer in a radially compressed state between the anterior and posterior native valve leaflets;

positioning a first ventricular anchor of the prosthetic spacer behind the posterior native valve leaflet;

positioning a second ventricular anchor of the prosthetic spacer behind the anterior native valve leaflet; and

allowing the spacer body to self-expand from the radially compressed state to a radially expanded state contacting inner surfaces of the anterior and posterior native valve leaflets.

2. The method of claim 1, wherein positioning the first ventricular anchor comprises positioning the first ventricular anchor behind the A2 region of the anterior native valve leaflet at a location free of chordae tendineae, and positioning the second ventricular anchor comprises positioning the second ventricular anchor behind the P2 region of the posterior native valve leaflet at a location free of chordae tendineae.

3. The method of claim 1, wherein prior to positioning the first and second ventricular anchors behind the native valve leaflets, the first and second ventricular anchors are expanded away from the main body while the main body is retained in a radially compressed state.

4. The method of claim 1, wherein at least one of the ventricular anchors extends in a ventricular direction from adjacent the spacer body and then curves to extend in an atrial direction toward a location behind the native valve leaflet.

5. The method of claim 4, wherein the at least one ventricular anchor extends beyond a ventricular end of the spacer body.

6. The method of claim 1, wherein at least one of the ventricular anchors is attached to the spacer body with one or more sleeves.

7. The method of claim 6, wherein the at least one ventricular anchor comprises a wire loop having first and second attachment ends, the spacer body has first and second prongs adjacent a ventricular end of the spacer body, a first sleeve secures the first attachment end to the first prong, and a second sleeve secures the second attachment end to the second prong.

8. The method of claim 6, wherein the one or more sleeves are crimped around a portion of the at least one ventricular anchor and a portion of the spacer body to secure them together.